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Xenical Rx-to-OTC switch review

Executive Summary

GlaxoSmithKline's NDA for over-the-counter use of orlistat (tetrahydrolipstatin) will be reviewed at a joint meeting of FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs advisory committees on Jan. 23. Orlistat is marketed as the prescription weight-loss drug Xenical by Roche; GSK acquired nonprescription marketing rights to the drug in July 2004. GSK filed an NDA for the Rx-to-OTC switch in June. [Editor's note: To 1watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...

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